# K820302: Surgipeel Self-Seal Packaging System

- Pathway: 510(k) (Traditional)
- Applicant: Surgicot, Inc.
- Decided: Feb 24, 1982 after 20 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070765: Vis-U-All II Self Seal Pouch (2007), 12 descendants of its own
- K090371: Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System (2009), 9 descendants of its own
- K140487: Vis-U-All Low Temperature Sterilization Pouch/Tubing (2014), 8 descendants of its own
- K160908: Vis-U-All Low Temperature Sterilization Pouch/Tubing (2016), 6 descendants of its own
- K172749: Vis-U-All Low Temperature Sterilization Pouch/Tubing (2018), 5 descendants of its own

Source page: https://510kreport.com/device/K820302
Methodology: https://510kreport.com/methodology