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510(k) K862729

PENN 3-RING HANDLE by Penn Medical Devices, Inc. — Product Code FFL

K862729 is an FDA 510(k) premarket notification submitted by Penn Medical Devices, Inc. for the device "PENN 3-RING HANDLE". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Penn Medical Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
July 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Basket, Ureteral, Metal
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type

Other clearances by Penn Medical Devices, Inc.

  • K873949 — RORERTAZZI NASOPHARYNGEAL AIRWAY (October 20, 1987)
  • K873177 — DEVINE (SUPRAPUBIC SOUND AND GUIDE) (October 14, 1987)
  • K873176 — HUFFMAN BIOPSY UNIT (October 14, 1987)
  • K873178 — URETERAL BULB DILATORS (September 30, 1987)
  • K871667 — URETERAL STENT (June 10, 1987)
  • K870508 — GASTROINTESTINAL TUBE (May 11, 1987)
  • K862107 — PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR (September 11, 1986)

Other clearances for product code FFL

  • K190492 — Peralta Stone Removal Catheter (July 18, 2019)
  • K172299 — Accordion Piccolo Stone Management Device (September 19, 2017)
  • K102887 — ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 (May 16, 2011)
  • K082803 — COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 (November 13, 2008)
  • K052048 — ACCORDION (September 13, 2005)
  • K012581 — REPROCESSED STONE RETRIEVAL BASKETS (February 14, 2002)
  • K972091 — AMS FOREIGN BODY EXTRATOR (August 29, 1997)
  • K970489 — COMEG ENDOSCOPY GRASPING FORCEPS (March 19, 1997)
  • K962387 — OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) (July 31, 1996)
  • K961248 — BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BA (May 28, 1996)

FDA data resources