Cleared Traditional

K934153 - WATTS RAKE WITH LEUR LOCK PORT

K934153 is an FDA 510(k) clearance for WATTS RAKE WITH LEUR LOCK PORT, 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 206-day FDA review.

K934153 · Phx Technologies Corp. · General & Plastic Surgery device
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Mar 1994
Decision
206d
Days
Class 2
Risk

K934153 is an FDA 510(k) clearance for the WATTS RAKE WITH LEUR LOCK PORT. 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 March 18, 1994 after a review of 206 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 - K934153

510(k) Number K934153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1993
Decision Date March 18, 1994
Days to Decision 206 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
91d slower than avg
Panel avg: 115d · This submission: 206d
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 K934153.
REFLEX HTR
K931879 · Richard-Allan Medical Ind., Inc. · Mar 1994
KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC
K934937 · KARL STORZ Endoscopy-America, Inc. · Mar 1994
SDR (SOFT DISSECTOR RAKE)
K935109 · Phx Technologies Corp. · Mar 1994
WATTS RAKE WITH LEUR PORT & AQUA-PROBE TIP
K934155 · Phx Technologies Corp. · Mar 1994
STRYKER ENDOSCOPIC VIDEO ACCESSORIES
K935234 · Stryker Endoscopy · Mar 1994
TROCAR TUBE
K940688 · Phx Technologies Corp. · Mar 1994