# K001330: Sovereign Bipolar Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: May 30, 2000 after 33 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: 4 generations back to K945975 (1994). 13 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954652: Aesculap Endosccopic Spine Instruments, Aesculap, Inc. (1996) Summary page 1.
- K992996: Enable Endoscopic Bipolar Scissors, Enable Medical Corp. (1999) Summary page 1.
- K983743: Bisure Laparoscopic Bipolar Forceps, Valleylab, Inc. (1999) Summary page 1.
- (no number) Jarit Detacho Bipolar System: named in the summary without a submission number

## Most influential descendants
- K030890: Switchblade (2003), 3 descendants of its own
- K113407: Snowden Pencer Laparoscopic Ergonomic Reposable Scissors (2012), 1 descendant of its own
- K160393: AdTec (2016), 0 descendants of its own
- K132232: Mins Needlescopic Resposable Device System (2013), 0 descendants of its own
- K123260: Detachatip Iii (2012), 0 descendants of its own

## Indications for use
The Sovereign Bipolar Instruments are intended to facilitate grasping, cutting and manipulation of soft tissue and blood vessels during laparoscopic procedures with the use of high-frequency electrical current (bipolar electrocautery).

Source page: https://510kreport.com/device/K001330
Methodology: https://510kreport.com/methodology