Device
Reusable Bipolar Forceps: Add Suction, Straight Tube (Special)
Manufacturer
KIRWAN SURGICAL PRODUCTS LLC
Model: 20-1417NSS DI: 00841019123836 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-13 Current Version: 2026-05-21
Description
Reusable Bipolar Forceps: Add Suction, Straight Tube (Special)
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 268c9032-7681-48f4-b30d-cf6f27412f01
Distribution Status: In Commercial Distribution
DUNS Number: 046355210
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Device ID: 00841019123836
Type: Primary
Issuing Agency: GS1
GMDN
Code: 47848
Name: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Definition:
A rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.
FDA Product Codes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
Premarket Submissions
Submission Number: K811820
Supplement Number: 000