Cleared Traditional

K911730 - SURGICAL OBTURATOR WITH SEAL

K911730 is the FDA 510(k) clearance for SURGICAL OBTURATOR WITH SEAL by Applied Vascular Devices, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K911730 · Applied Vascular Devices, Inc. · General & Plastic Surgery device
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Dec 1991
Decision
250d
Days
Class 2
Risk

K911730 is an FDA 510(k) clearance for the SURGICAL OBTURATOR WITH SEAL. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Applied Vascular Devices, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on December 23, 1991 after a review of 250 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 Applied Vascular Devices, Inc. devices

Submission Details

510(k) Number K911730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date December 23, 1991
Days to Decision 250 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 115d · This submission: 250d
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 694
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K911730.
LAPAROSCOPIC SNARE POUCH
K915360 · United States Endoscopy Group, Inc. · Jan 1992
ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR
K915239 · Ethicon, Inc. · Jan 1992
ASP-IRRATOR
K914997 · Conmedcorp · Jan 1992
SUCTION/IRRIGATION KITTNER
K914781 · O.R. Concepts, Inc. · Dec 1991
SUCTION/IRRIGATION PROBE
K914782 · O.R. Concepts, Inc. · Dec 1991
ETHICON ABSORBABLE SUTURE CLIP AND APPLIER
K914549 · Ethicon, Inc. · Dec 1991