Cleared Traditional

K001068 - NBS CONNECTING TUBE SET

K001068 is an FDA 510(k) clearance for NBS CONNECTING TUBE SET, manufactured by Nbs Products CO. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K001068 · Nbs Products CO · Obstetrics & Gynecology device
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Jun 2000
Decision
72d
Days
Class 2
Risk

K001068 is an FDA 510(k) clearance for the NBS CONNECTING TUBE SET. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Nbs Products CO (New Brunswick, US). The FDA issued a Cleared decision on June 14, 2000 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology 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 Nbs Products CO devices

FDA 510(k) Submission Details - K001068

510(k) Number K001068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2000
Decision Date June 14, 2000
Days to Decision 72 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 160d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 126
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K001068.
TAUT-INSUFFLATION NEEDLE
K003703 · Taut, Inc. · Feb 2001
STRYKER HEATED INSUFFLATOR TUBE SET
K003792 · Stryker Corp. · Feb 2001
INSUFFLATION NEEDLE- 120MM, MODEL 900-200
K993625 · Genicon, LC · Jun 2000
INSUFFLATION NEEDLE, MODEL R65-933
K000027 · A & A Medical, Inc. · Apr 2000
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
K991906 · Richard Wolf Medical Instruments Corp. · Nov 1999
DISPOSABLE HEATING TUBING SET #7642HSES
K990662 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Sep 1999