Cleared Traditional

K940948 - ANGLED DISSECTORS MODELS 8383.581/582/571

K940948 is an FDA 510(k) clearance for ANGLED DISSECTORS MODELS 8383.581/582/571, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K940948 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
143d
Days
Class 2
Risk

K940948 is an FDA 510(k) clearance for the ANGLED DISSECTORS MODELS 8383.581/582/571. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on July 21, 1994 after a review of 143 days - within the typical 510(k) review window.

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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K940948

510(k) Number K940948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1994
Decision Date July 21, 1994
Days to Decision 143 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
28d slower than avg
Panel avg: 115d · This submission: 143d
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 1066
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K940948.
OLYMPUS SUPERVIEW LAPAROSCOPE FOR GENERAL SURGERY
K942839 · Olympus America, Inc. · Jul 1994
REUSABLE PROBES
K943070 · Surgin Surgical Instrumentation, Inc. · Jul 1994
AESCULAP FLEXIBLE TROCAR INSTRUMENT SET
K935243 · Aesculap, Inc. · Jul 1994
DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH
K942879 · Deroyal Industries, Inc. · Jul 1994
LIFTING DISTENTION BALLOON SYSTEM
K942678 · Origin Medsystems, Inc. · Jul 1994
ORIGIN BALLOON RETRACTOR
K942491 · Origin Medsystems, Inc. · Jul 1994