# K070352: Mini Lap Pediatric Instruments with Medusa Clamping System

- Pathway: 510(k) (Traditional)
- Applicant: Mini Lap Technologies, Inc.
- Decided: Apr 5, 2007 after 58 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- 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 K992904 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010007: Adapt Laparoscopic Port & Adapt Reducer Cap, Taut, Inc. (2001). Our OCR of the scanned summary read K012007, FDA’s number for RHS Helmet (Restorative Health Svs, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Taut— Adapt Pediatric Access Ports”.
- K992904: Mini-Port, Taut, Inc. (1999) Summary page 5.
- (no number) Stryker — Pediatric Surgical Instruments: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K951173: Manual Surgical Instrument for General Use, United States Surgical, A Division of Tyco Healthc (1995). Our OCR of the scanned summary read K951173, FDA’s number for Manual Surgical Instrument for General Use (United States Surgical, A Division of Tyco Healthc). Its FDA name has none of the distinctive words the summary uses for the device it names, “U.S. Surgical Corp - MiniSite 2mm Laparoscopic Instruments”. Kept off the family tree. Summary page 5.
- K062326: Autosuture Modified Versaport Trocar with Fixation Sleeve, United States Surgical, A Division of Tyco Healthc (2006). Our OCR of the scanned summary read K062326, FDA’s number for Autosuture Modified Versaport Trocar with Fixation Sleeve (United States Surgical, A Division of Tyco Healthc). Its FDA name has none of the distinctive words the summary uses for the device it names, “U.S. Surgical Corp — MiniPort 2mm”. Kept off the family tree. Summary page 5.

## Most influential descendants
- K172775: MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle (2018), 0 descendants of its own

## Indications for use
The MINI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.

Source page: https://510kreport.com/device/K070352
Methodology: https://510kreport.com/methodology