Cleared Traditional

K933985 - MICROWAVE INSURG INTRODUCER

K933985 is the FDA 510(k) clearance for MICROWAVE INSURG INTRODUCER by Boston Scientific Corp. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K933985 · Boston Scientific Corp · General & Plastic Surgery device
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Nov 1993
Decision
88d
Days
Class 2
Risk

K933985 is an FDA 510(k) clearance for the MICROWAVE INSURG INTRODUCER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on November 12, 1993 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K933985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1993
Decision Date November 12, 1993
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K933985.
PHX TECHNOLOGIES CORP., ISDS-2000, IRRIGATION SOLUTION DELIVERY SYSTEM
K934725 · Phx Technologies Corp. · Nov 1993
FORCEPS FOR LAPAROSCOPIC SURGERY GU USE
K925959 · Zinnanti Surgical Instruments, Inc. · Nov 1993
NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE
K926016 · Zinnanti Surgical Instruments, Inc. · Nov 1993
COMED TROGARD(TM) BLUNT TIP TROCAR/SLEEVE
K933456 · Conmedcorp · Nov 1993
LAPAROSCOPIC BALLOON RETRACTOR
K926480 · Origin Medsystems, Inc. · Oct 1993
ENDOPATH EP DISPOSABLE TROCAR
K922608 · Ethicon, Inc. · Oct 1993