Cleared Traditional

K934165 - STERILE

K934165 is an FDA 510(k) clearance for STERILE, manufactured by Phx Technologies Corp.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K934165 · Phx Technologies Corp. · General & Plastic Surgery device
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Jan 1994
Decision
154d
Days
Class 2
Risk

K934165 is an FDA 510(k) clearance for the STERILE, DISPOSABLE ENDO SPECIEMEN RETRIEVAL BAG. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Phx Technologies Corp. (Lewisville, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 154 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 Phx Technologies Corp. devices

FDA 510(k) Submission Details - K934165

510(k) Number K934165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1993
Decision Date January 25, 1994
Days to Decision 154 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 115d · This submission: 154d
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 723
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K934165.
PREPERITONEAL DISTENTION BALLOON SYSTEM
K935426 · Origin Medsystems, Inc. · Jan 1994
ENDOSCOPIC NEEDLE DRIVER
K933725 · United States Surgical, A Division of Tyco Healthc · Jan 1994
PHX TECHOLOGIES CORP., 5MM STERILE, DISPOSABLE ENDOSCOPIC KITTNER BLUNT DISSECTING INSTRUMENT
K934077 · Phx Technologies Corp. · Jan 1994
PHX TECHNOLOGIES CORP., 5MM, 10MM, AND 12MM BLUNT-TIPPED TROCAR OBTURATORS AND MATCHED TROCAR TUBES
K934279 · Phx Technologies Corp. · Jan 1994
PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE
K934280 · Phx Technologies Corp. · Jan 1994
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
K932346 · Aesculap, Inc. · Jan 1994