Cleared Traditional

K914781 - SUCTION/IRRIGATION KITTNER

K914781 is an FDA 510(k) clearance for SUCTION/IRRIGATION KITTNER, manufactured by O.R. Concepts, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K914781 · O.R. Concepts, Inc. · General & Plastic Surgery device
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Dec 1991
Decision
47d
Days
Class 2
Risk

K914781 is an FDA 510(k) clearance for the SUCTION/IRRIGATION KITTNER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by O.R. Concepts, Inc. (Roanoke, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 47 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 O.R. Concepts, Inc. devices

FDA 510(k) Submission Details - K914781

510(k) Number K914781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1991
Decision Date December 09, 1991
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K914781.
ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR
K915239 · Ethicon, Inc. · Jan 1992
ASP-IRRATOR
K914997 · Conmedcorp · Jan 1992
MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS
K913954 · Marlo Surgical Technology · Dec 1991
SUCTION/IRRIGATION PROBE
K914782 · O.R. Concepts, Inc. · Dec 1991
ETHICON ABSORBABLE SUTURE CLIP AND APPLIER
K914549 · Ethicon, Inc. · Dec 1991
PNEUMO-SEAL(TM)
K914470 · Edward Weck, Inc. · Nov 1991