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Ranfac IN-12 — single-use 12 cm laparoscopic insufflation needle
FDA Cleared · K930474 Single Use · Sterile EO Latex-Free
General Surgery · Insufflation

IN-12 Insufflation Needle (12 cm)

The IN-12 is a single-use 12 cm insufflation needle for laparoscopic pneumoperitoneum establishment. Designed for safe percutaneous CO₂ delivery prior to trocar placement.

CatalogIN-12
Part #68017-01M
DeviceInsufflation Needle
Length12 cm
SterilitySterile (EO)
ClearanceK930474

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Overview

The Ranfac IN-12 is a single-use 12 cm insufflation needle for laparoscopic pneumoperitoneum establishment. The device provides controlled percutaneous CO₂ delivery into the peritoneal cavity prior to trocar placement, with a spring-loaded blunt obturator design family that retracts on tissue resistance and extends in open space — minimizing visceral injury risk on entry. Each device ships sterile, ethylene-oxide processed, and individually packaged.

The IN-12 is the laparoscopic-setup device in the Ranfac surgical-instrument portfolio. Used at the start of the procedure to establish pneumoperitoneum, before trocar placement. Pairs with the rest of the Ranfac MIS family for trocar site closure (RSG-14), percutaneous access (PIN-15), and intraoperative cholangiography (LAP-13, XL-11).

Clinical Applications

Refer to the device Instructions for Use for the full indications, contraindications, warnings, and procedure. The IN-12 is intended for the establishment of pneumoperitoneum during laparoscopic surgical procedures.

Surgeons use insufflation needles to establish pneumoperitoneum prior to trocar placement in laparoscopic procedures. The 12 cm length is suited to standard-anatomy abdominal access through subumbilical or alternative-site approaches.

General Laparoscopy

Pneumoperitoneum establishment prior to trocar placement in standard laparoscopic procedures.

Bariatric & Foregut

Insufflation for procedures where standard-length insufflation needles are appropriate.

Gynecology & Urology

Pelvic laparoscopic procedure setup.

Standard MIS Workflows

Used across general, bariatric, gynecologic, and urologic laparoscopic procedures where the device is part of the surgeon's standard instrument set.

Specifications

IN-12 Technical Data

Construction, regulatory, and packaging details. Gauge, length, cannula and stylet are listed in the hero above. For complete indications, contraindications, and warnings, download the Instructions for Use.

ConstructionStainless steel components · medical-grade polymer hub
ConnectionStandard luer connections per device IFU
SterilizationEthylene oxide · single-use · latex-free
PackagingIndividually pouched
FDA Clearance510(k) K930474 · Class II
PrescriptionRx only (21 CFR 801 Subpart D)

Directions for Use (Summary)

The following is a high-level summary. Refer to the device Instructions for Use for complete procedure, contraindications, and warnings.

  1. Inspect packaging. Confirm integrity; if undamaged, open using aseptic technique.
  2. Inspect the device. Verify mechanism function and component integrity prior to use.
  3. Select insertion site per surgical plan (typically subumbilical or alternative point).
  4. Insert the needle through the abdominal wall under controlled pressure.
  5. Confirm intraperitoneal placement per standard tests (aspiration, hanging-drop, saline) before initiating gas flow.
  6. Connect insufflator tubing and begin CO₂ insufflation at the surgeon's selected flow rate and pressure limit.
  7. Monitor pressure until target pneumoperitoneum is achieved.
  8. Remove needle prior to trocar placement.
  9. Dispose in a sharps biohazard container per facility policy.

Documents & Downloads

Frequently Asked Questions

What is the IN-12 used for?

Establishment of pneumoperitoneum during laparoscopic surgical procedures — controlled percutaneous CO₂ delivery into the peritoneal cavity prior to trocar placement.

What length is the IN-12?

12 cm. The catalog code IN-12 reflects the 12 cm working length.

Is the IN-12 FDA cleared?

Yes, under 510(k) K930474 as a Class II surgical instrument.

Is the device reusable?

No. The IN-12 is a single-use device — supplied sterile and disposed of after a single procedure per facility policy.

What sterilization method is used?

Ethylene oxide (EO). The device is shipped sterile and is not made with natural rubber latex.

How is intraperitoneal placement confirmed before insufflation?

Standard pneumoperitoneum-establishment tests apply: aspiration (looking for absence of blood or enteric content), the hanging-drop test, and saline-injection tests. Confirm placement per facility protocol before initiating CO₂ gas flow.

Related Products

Other configurations in the Ranfac General Surgery family.

RSG-14 — RSG-14 Puncture Closure Device

RSG-14

Single-use percutaneous puncture-closure device for laparoscopic trocar site management

View →
PIN-15 — PIN-15 Percutaneous Introducer Needle

PIN-15

Single-use percutaneous introducer needle for guidewire placement and percutaneous access

View →
LAP-13 — LAP-13 Cholangiography Catheter (Port Access)

LAP-13

Single-use cholangiography catheter for laparoscopic intraoperative bile duct imaging via trocar port access

View →
XL-11 — XL-11 Cholangiography Catheter (Percutaneous Access)

XL-11

Single-use cholangiography catheter for percutaneous intraoperative bile duct imaging

View →

Order or Request a Sample of the IN-12

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