PATCHASSIST— 510(k) K101218

Substantially Equivalent

Polytouch Medical, Ltd.

FDA 510(k) clearance K101218 for PATCHASSIST, Substantially Equivalent on 2010-06-17. Applicant: Polytouch Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Polytouch Medical, Ltd.
Product code: Code ORQ
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2010-04-30
Decision date: 2010-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ORQ

K250395 — BioBrace ® RC Delivery System2025-04-07
K130782 — ACCUMESH DEPLOYMENT SYSTEM2013-04-05
K123066 — ACCUMESH DEPLOYMENT SYSTEM2012-10-16
K121139 — ACCUMESH DEPLOYMENT SYSTEM2012-05-02
K103269 — PATCHASSIST LARGE2010-11-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.