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510(k) K761229

ANAL/RECTAL SYRINGE by Ace Orthopedic Manufacturing Co. — Product Code KOA

K761229 is an FDA 510(k) premarket notification submitted by Ace Orthopedic Manufacturing Co. for the device "ANAL/RECTAL SYRINGE". The FDA issued a decision of Substantially Equivalent on February 24, 1977. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. Ace Orthopedic Manufacturing Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1977
Date Received
December 10, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Ace Orthopedic Manufacturing Co.

  • K934643 — ACE HUMERAL NAIL (March 22, 1994)
  • K934962 — AIM SUPRACONDYLAR NAIL (March 22, 1994)
  • K936045 — ACE UNILATERAL FIXATOR II (February 22, 1994)
  • K926047 — ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW (March 31, 1993)
  • K920738 — ACE 100 DEGREES TUBULAR PLATE (July 27, 1992)
  • K813554 — ACE/KYLE CAPTURED HIP SCREW (January 12, 1982)
  • K810193 — TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG (March 20, 1981)
  • K801594 — ACE FISCHER EXTERNAL FIXATION DEVICE (September 9, 1980)
  • K791466 — ACE EXTERNAL BONE CLAMP PART #S11 (August 16, 1979)
  • K781841 — BAR, DISTRACTION (November 8, 1978)

Other clearances for product code KOA

  • K182664 — FiXcision (December 7, 2018)
  • K950267 — URETHRAL SUTURE GUIDE (January 31, 1995)
  • K932465 — LI VASECTOMY (March 2, 1994)
  • K921546 — VASOVASOSTOMY SET (July 2, 1993)
  • K931181 — VESITEC SUTURE PASSER (May 12, 1993)
  • K921304 — DDV LIGATOR (October 5, 1992)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (September 23, 1992)
  • K921228 — BENDEREV PROTECT-A-PASS NEEDLE (September 14, 1992)
  • K922192 — VAS DILATOR (August 7, 1992)
  • K896058 — GRASPING FORCEPS (December 28, 1989)

FDA data resources