# K981579: Endopouch Pro Specimen Retrieval Bag

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jul 9, 1998 after 66 days
- Product code: MDM (Instrument, Manual, Surgical, General Use)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) ENDOPOUCH II Specimen Retrieval Bag: named in the summary without a submission number
- (no number) Auto Suture ENDO CATCH Specimen Retrieval Bag: named in the summary without a submission number

## Indications for use
ENDOPOUCH PRO Specimen Retrieval Bag is a disposable device used as a receptacle for the collection and extraction of tissue specimens such as appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi during laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K981579
Methodology: https://510kreport.com/methodology