# K972510: Pivotal Scissor

- Pathway: 510(k) (Traditional)
- Applicant: Urohealth Systems, Inc.
- Decided: Nov 13, 1997 after 133 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Auto Suture Endo Instruments: named in the summary without a submission number
- (no number) Auto Suture Roticulator Instruments: named in the summary without a submission number
- (no number) Endopath Instruments: named in the summary without a submission number
- (no number) Reflex Smm Laparoscopic Scissors: named in the summary without a submission number
- (no number) Ethicon PowerStar: named in the summary without a submission number

## Most influential descendants
- K043541: Endolink True Movement System (2005), 4 descendants of its own
- K071488: Realhand High Dexterity (HD) Instruments (2007), 2 descendants of its own
- K072715: Realhand High Dexterity Instruments (2007), 1 descendant of its own
- K212736: Canady Flex RoboWrist (2022), 0 descendants of its own
- K072811: Marionette SA, Model 001 001 & 001 002 (2008), 0 descendants of its own

## Indications for use
The Pivotal devices are sterile, disposable, general surgical instruments for use in endoscopic or open surgical procedures to dissect, transect, manipulate, coagulate, and/or grasp tissue.

Source page: https://510kreport.com/device/K972510
Methodology: https://510kreport.com/methodology