# K033421: Erbe Biclamp Open and Laparoscopic Instruments

- Pathway: 510(k) (Abbreviated)
- Applicant: Erbe USA, Inc.
- Decided: Oct 14, 2004 after 353 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: 2 generations back to K932293 (1994). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 1.

## Most influential descendants
- K091259: Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps (2010), 0 descendants of its own
- K060170: Erbe Biclamp Open and Laparoscopic Instruments (2006), 0 descendants of its own

## Indications for use
The ERBE BiClamp TM 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 BiClampTM Open and Laparoscopic Instruments are designed for use with an ERBE VIO Electrosurgical Generator (ESU) System having an Optional Bipolar Mode/ BiClamp TM 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/K033421
Methodology: https://510kreport.com/methodology