# K014183: Afb (Absorbable Foam Buttress)

- Pathway: 510(k) (Traditional)
- Applicant: J&J Corporate Biomaterials Center
- Decided: Jun 12, 2002 after 174 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
Longest line of descent: 4 generations back to K842066 (1985). 15 ancestors in all.
145 later devices descend from it; 2 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923657: Supple Peri-Guard, Bio-Vascular, Inc. (1992) Summary page 1.
- K940205: Peri-Strips, Bio-Vascular, Inc. (1994) Summary page 1.
- K942583: Peri-Strips Planar Configuration Staple Line Reinforcement, Bio-Vascular, Inc. (1994) Summary page 1.
- K971048: Peri-Strips Dry - Staple Line Reinforcement, Bio-Vascular, Inc. (1997) Summary page 1.
- K992537: Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-Treated, Bio-Vascular, Inc. (2000) Summary page 1.
- K955364: Seamguard Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (1996) Summary page 1.
- K001789: Seamguard Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2000)
- K915835: Coated Vicryl* II, ETHICON, Inc. (1992) Summary page 1.
- K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified), ETHICON, Inc. (1996) Summary page 1.
- K964072: Monocryl (Poliglecaprone 25) Suture, Undyed, ETHICON, Inc. (1996) Summary page 1.

## Most influential descendants
- K030782: Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 143 descendants of its own
- K032865: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 102 descendants of its own
- K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2004), 77 descendants of its own
- K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration (2004), 69 descendants of its own
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement (2008), 48 descendants of its own

## Indications for use
AFB is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed.

Source page: https://510kreport.com/device/K014183
Methodology: https://510kreport.com/methodology