Cleared Traditional

K101193 - PMC LAPAROSCOPIC INSTRUMENTS

K101193 is an FDA 510(k) clearance for PMC LAPAROSCOPIC INSTRUMENTS, manufactured by Pmc Medical GmbH. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K101193 · Pmc Medical GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
173d
Days
Class 2
Risk

K101193 is an FDA 510(k) clearance for the PMC LAPAROSCOPIC INSTRUMENTS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Pmc Medical GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on October 18, 2010 after a review of 173 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pmc Medical GmbH devices

FDA 510(k) Submission Details - K101193

510(k) Number K101193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2010
Decision Date October 18, 2010
Days to Decision 173 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 115d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 912
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K101193.
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
K112456 · Teleflexmedical, Inc. · Oct 2011
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
K101077 · Intuitive Surgical, Inc. · Feb 2011
LTF-Y0009
K102379 · Olympus Medical Systems Corporation · Jan 2011
HYBRID TROCAR SYSTEM
K101937 · Aesculap, Inc. · Aug 2010
SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
K101671 · Teleflexmedical, Inc. · Jun 2010
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
K092789 · Terumo Cardiovascular Systems Corp. · May 2010