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510(k) K990935

JACKSON ESOPHAGEAL DILATOR by Pilling Weck Surgical — Product Code KNQ

K990935 is an FDA 510(k) premarket notification submitted by Pilling Weck Surgical for the device "JACKSON ESOPHAGEAL DILATOR". The FDA issued a decision of Substantially Equivalent on May 17, 1999. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Pilling Weck Surgical has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1999
Date Received
March 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Esophageal
Device Class
Class II
Regulation Number
876.5365
Review Panel
GU
Submission Type

Other clearances by Pilling Weck Surgical

  • K992476 — PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS (September 13, 2000)
  • K992174 — PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP (March 23, 2000)
  • K990561 — OPTICAL FORCEPS (May 14, 1999)
  • K982128 — SHIKANI-FRENCH SPEAKING VALVE (October 23, 1998)

Other clearances for product code KNQ

  • K122924 — CRE FIXED WIRE BALLON DILATION CATHETER (October 24, 2012)
  • K093236 — ETHICON ENDO-SURGERYOPTICAL DILATOR (November 10, 2009)
  • K090183 — HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON (September 25, 2009)
  • K082995 — SMART DILATOR (February 6, 2009)
  • K061937 — COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (December 1, 2006)
  • K061787 — MAXFORCE TTS SINGLE-USE BALLOON DILATOR (September 21, 2006)
  • K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED (April 11, 2006)
  • K043605 — INSCOPE 3-STAGE BALLOON DILATOR (February 4, 2005)
  • K033936 — BARD ELIMINATOR PET BALLOON DILATORS (January 14, 2004)
  • K031147 — OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR (January 12, 2004)

FDA data resources