# K990663: Intromit Hand Access Port for Hand Assisted Laparoscopic Surgery, Model FP880-150

- Pathway: 510(k) (Traditional)
- Applicant: Medtech, Ltd.
- Decided: May 27, 1999 after 87 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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) Pilling Weck’s Dexterity® Pneumo Sleeve and Protector® Retractor: named in the summary without a submission number
- (no number) Karl Storz Endoscopy America, Inc.’s trocars and cannulas for endoscopic and laparoscopic procedures: named in the summary without a submission number
- (no number) Solos Endoscopy Inc. GS-4300 Cannula and Trocar and GS-4500 Cannula and Trocar: named in the summary without a submission number
- (no number) Marlow Surgical Technologies Hasson SAC Cannula: named in the summary without a submission number
- (no number) Ethicon, Inc.’s Endopath Trocar: named in the summary without a submission number
- (no number) Innerdyne Medical ‘Step” Radical Expansion Obturator/Cannula: named in the summary without a submission number

## Most influential descendants
- 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
- K100180: Surgiquest Anchorport Sil Kit (2010), 0 descendants of its own

## Indications for use
The Intromit is inserted into the patient’s abdomen to provide abdominal access for the surgeon’s hand while preserving the peritoneum during laparoscopic surgery.

Source page: https://510kreport.com/device/K990663
Methodology: https://510kreport.com/methodology