Cleared Traditional

K761229 - ANAL/RECTAL SYRINGE

K761229 is an FDA 510(k) clearance for ANAL/RECTAL SYRINGE, manufactured by Ace Orthopedic Manufacturing Co.. The device is a Class 1 Gastroenterology & Urology device with product code KOA cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K761229 · Ace Orthopedic Manufacturing Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1977
Decision
76d
Days
Class 1
Risk

K761229 is an FDA 510(k) clearance for the ANAL/RECTAL SYRINGE. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Ace Orthopedic Manufacturing Co. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1977 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - the FDA gastroenterology and urology 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 Ace Orthopedic Manufacturing Co. devices

FDA 510(k) Submission Details - K761229

510(k) Number K761229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1976
Decision Date February 24, 1977
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 131d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

KOA Device Classification - Class 1, General Controls

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KOA Surgical Instruments, G-u, Manual (and Accessories)

All 30
Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K761229.
CIRCLE NEPHROSTOMY TUBE INTRODUCER
K810533 · American V. Mueller · Mar 1981
MAGILL CATHETER INTRO. FORCEPS
K801273 · J. Sklar Mfg. Co., Inc. · Jul 1980
RUDD-CLINIC HEMORRHOIDAL FORCEPS
K800441 · J. Sklar Mfg. Co., Inc. · Apr 1980
FLEXIBLE CUTTING SCISSORS
K760715 · V. Mueller O.V. Baxter Healthcare Corp. · Oct 1976
FLEXIBLE BIOPSY FORCEPS
K760717 · V. Mueller O.V. Baxter Healthcare Corp. · Oct 1976
FLEXIBLE FOREIGN BODY FORCEPS
K760716 · V. Mueller O.V. Baxter Healthcare Corp. · Oct 1976