Cleared Traditional

K934527 - FASCIA STITCHER

K934527 is an FDA 510(k) clearance for FASCIA STITCHER, manufactured by Laparomed Corp.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K934527 · Laparomed Corp. · General & Plastic Surgery device
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Feb 1994
Decision
158d
Days
Class 2
Risk

K934527 is an FDA 510(k) clearance for the FASCIA STITCHER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Laparomed Corp. (Irvine, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 158 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 Laparomed Corp. devices

FDA 510(k) Submission Details - K934527

510(k) Number K934527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1993
Decision Date February 25, 1994
Days to Decision 158 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 115d · This submission: 158d
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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K934527.
FLOWGUN REUSABLE IRRIGATION PROBES
K935645 · O.R. Concepts, Inc. · Mar 1994
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
K926479 · Davol, Inc. · Mar 1994
SENSING TIP SURGICAL TROCAR
K930848 · Origin Medsystems, Inc. · Mar 1994
STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
K934094 · Stryker Corp. · Feb 1994
5,6,7,9,10,11&12MM BLUNT-TIPPED TROCAR OBTURATORS
K934511 · Phx Technologies Corp. · Feb 1994
YANKAUER WITH CONNECTING TUBING
K934750 · Trinity Laboratories, Inc. · Feb 1994