# K962147: Dexterity Pneumo Sleeve Set

- Pathway: 510(k) (Traditional)
- Applicant: Medical Creative Technologies, Inc.
- Decided: Jul 9, 1996 after 36 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954824 (1996). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954824: Protector Retractor & Protector Retractor with Drape, Medical Creative Technologies, Inc. (1996) Summary page 2.
- (no number) Trocar/Cannula by Storz: named in the summary without a submission number

## Most influential descendants
- K990414: Smith & Nephew Handport System (1999), 5 descendants of its own
- K014047: Applied Gelport Laparoscopic Hand Access Device (2002), 4 descendants of its own
- K090275: Gelport Single Incision Access System (2009), 3 descendants of its own
- K202688: AFS Medical Sterile Single-Use Access Port System (2021), 0 descendants of its own
- K120898: Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar 8850XX Sealing CA (2012), 0 descendants of its own

## Indications for use
The Dexterity® Pneumo Sleeve is intended to provide abdominal access for the surgeon’s hand while preserving pneumoperitoneum during laparoscopic surgery. The Protector® Retractor is intended to provide incision retraction and to protect it against wound contamination during both laparoscopic and open surgery. This device allows the surgeon to use his hand while performing corrective surgery in the abdominal cavity under pneumoperitoneum.

Source page: https://510kreport.com/device/K962147
Methodology: https://510kreport.com/methodology