# K993801: Gynecare Laparoscopic Morcellator

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Feb 7, 2000 after 90 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 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) Gynecare Laparoscopic Morcellator: named in the summary without a submission number

## Most influential descendants
- K101458: Lina Xcise Model  Mor-1515 (2011), 1 descendant of its own
- K080093: PKS Plasma Morcellator, Models 962000PK, 3620PK (2008), 1 descendant of its own
- K243821: i-Cut (2025), 0 descendants of its own
- K161038: PK Morcellator (2016), 0 descendants of its own
- K091010: Trokamed Morcellator (2011), 0 descendants of its own

## Indications for use
Indicated for cutting, coring and extracting tissue in operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures such as nephrectomy, and laparoscopic gynecologic procedures such as myomectomy and hysterectomy.

Source page: https://510kreport.com/device/K993801
Methodology: https://510kreport.com/methodology