Cleared Traditional

K935878 - GLASSER SUTURE NEEDLE

K935878 is an FDA 510(k) clearance for GLASSER SUTURE NEEDLE, manufactured by Advanced Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K935878 · Advanced Surgical, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
62d
Days
Class 2
Risk

K935878 is an FDA 510(k) clearance for the GLASSER SUTURE NEEDLE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Advanced Surgical, Inc. (Princeton, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 62 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 Advanced Surgical, Inc. devices

FDA 510(k) Submission Details - K935878

510(k) Number K935878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1993
Decision Date February 09, 1994
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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 826
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K935878.
FLUID ASPIRATION NEEDLE
K935293 · Surgin Surgical Instrumentation, Inc. · Feb 1994
SURGICAL RETRACTOR KIT
K940193 · Advanced Surgical, Inc. · Feb 1994
INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION
K934338 · Innovasive Devices, Inc. · Feb 1994
I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA
K934097 · Sharplan Lasers, Inc. · Feb 1994
LAPAROSCOPIC TROCAR STARTER SCALPEL
K936154 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
BIOPSY CUP FORCEPS
K930180 · Surgical Technologies, Inc. · Feb 1994