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510(k) K981611

SNAP-N-PEEL INTRODUCERS by Circon Corp. — Product Code KNY

K981611 is an FDA 510(k) premarket notification submitted by Circon Corp. for the device "SNAP-N-PEEL INTRODUCERS". The FDA issued a decision of Substantially Equivalent on July 30, 1998. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Circon Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1998
Date Received
May 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Circon Corp.

  • K992544 — TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM (October 26, 1999)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K980972 — RIGID CULDOSCOPE AND ACCESSORIES (June 12, 1998)
  • K973820 — USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECT (May 12, 1998)
  • K964594 — VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VA (August 15, 1997)

Other clearances for product code KNY

  • K260919 — Transurethral Catheter Safety Valve (TUCSV) (80050) (August 5, 2026)
  • K182144 — Bi-Flex Evo (September 7, 2018)
  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE (June 16, 2014)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)
  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)

FDA data resources