# K981756: Shelhigh NO-React Pneumopledgets

- Pathway: 510(k) (Traditional)
- Applicant: Shelhigh, Inc.
- Decided: Aug 5, 1998 after 79 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: 2 generations back to K964467 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940205: Peri-Strips, Bio-Vascular, Inc. (1994). Our OCR of the scanned summary read K340205, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Peri-Strips®”.
- K974914: Shelhigh NO-React Pericardial Patches, Shelhigh, Inc. (1998). Cleared while this submission was under review Summary page 2.
- K964467: Shelhigh Pericardial Patch, Shelhigh, Inc. (1997) Summary page 2.

## Most influential descendants
- K991567: Shelhigh NO-React Tissue Repair Patch/Uropatch. (1999), 0 descendants of its own

## Indications for use
The device is intended for use to reinforced the soft tissue of the lung, thereby sealing or reducing air leak that occur during pulmonary surgery.

Source page: https://510kreport.com/device/K981756
Methodology: https://510kreport.com/methodology