# K992556: Permacol

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Science Laboratories, Plc
- Decided: Feb 17, 2000 after 202 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
170 later devices descend from it; 8 cite it directly.
0 of 171 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) Polymeric Surgical Mesh: named in the summary without a submission number
- (no number) GraftPatch®: named in the summary without a submission number
- (no number) Rapi-Seal™ Patch: named in the summary without a submission number
- (no number) Biosynthetic Surgical Mesh: named in the summary without a submission number
- (no number) Peri-Guard® family of products: named in the summary without a submission number
- (no number) Glycar Tissue Repair Patch: named in the summary without a submission number

## Most influential descendants
- K013625: Permacol (2002), 95 descendants of its own
- K034039: Sis Plastic Surgery Matrix (2004), 93 descendants of its own
- K043366: Permacol Surgical Implant (2004), 74 descendants of its own
- K020455: Tissuemend Soft Tissue Repair Matrix (2002), 56 descendants of its own
- K050355: Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150 (2005), 54 descendants of its own

## Indications for use
Permacol™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical and incisional hernias; colon, rectal, urethral and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor and procedures such as sacrocolposuspension and urethral sling.

Source page: https://510kreport.com/device/K992556
Methodology: https://510kreport.com/methodology