# K060170: Erbe Biclamp Open and Laparoscopic Instruments

- Pathway: 510(k) (Special)
- Applicant: Erbe USA, Inc.
- Decided: Feb 16, 2006 after 24 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932293 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033421: Erbe Biclamp Open and Laparoscopic Instruments, Erbe USA, Inc. (2004) Summary page 1.
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 1.

## Indications for use
The ERBE BiClamp Open and Laparoscopic Instruments are intended for use in general surgery, laparoscopic, gynecologic, urological, and thoracic procedures where fusion of vessels or tissues is desired. The devices can be used on vessels up to 7 mm and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument. The ERBE BiClamp Open and Laparoscopic Instruments are designed for use with an ERBE VIO Electrosurgical Generator (ESU) System having an Optional Bipolar Mode/BiClamp upgrade and the multi-function receptacle. Not recommended for use with other manufacturer's generators. The indications for use with Open Instruments include: general surgery, gynecologic, urological, and thoracic procedures where fusion of vessels and tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc. The indications for use with Laparoscopic Instruments include: all laparoscopic procedures (including gynecologic, general, urological, and thoracic surgery) where fusion of vessels or tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholecystectomies (gall bladder procedures), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc. CAUTION: Vessel fusion can be affected by patient factors such as age, elasticity of vessels, thickness of vessel walls, etc.; therefore, the physician should review each vessel fusion for seal integrity. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.

Source page: https://510kreport.com/device/K060170
Methodology: https://510kreport.com/methodology