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510(k) K922971

NO-SCALPEL VASCETOMY INSTRUMENTS by Pilling Co. — Product Code KOA

K922971 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "NO-SCALPEL VASCETOMY INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on September 23, 1992. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. Pilling Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1992
Date Received
June 19, 1992
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 Pilling Co.

  • K002582 — PILLING E-FRAZIER BIPOLAR SUCTION TUBE (November 3, 2000)
  • K934427 — PILLING LAPAROSCOPIC INSTRUMENTATION (January 10, 1994)
  • K925370 — TRIANGULAR JAW MICROLARYNGEAL FORCEPS (March 18, 1993)
  • K925198 — KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR (February 12, 1993)
  • K914015 — CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP (November 21, 1991)
  • K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (June 25, 1991)
  • K911100 — MEHIGAN-PILLING PHLEBETOME TM (June 21, 1991)
  • K904507 — PILLING BRUSH VALVULOTOME (March 1, 1991)
  • K884946 — JEHLE CORONARY PERFUSION CATHETERS (February 6, 1989)
  • K882930 — LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX (August 16, 1988)

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)
  • K921228 — BENDEREV PROTECT-A-PASS NEEDLE (September 14, 1992)
  • K922192 — VAS DILATOR (August 7, 1992)
  • K896058 — GRASPING FORCEPS (December 28, 1989)
  • K891352 — MARLOW ANAL SPECULUM (June 23, 1989)

FDA data resources