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510(k) K870698

VAN-TEC PROSTATE BIOPSY NEEDLE by Van-Tec, Inc. — Product Code KNN

K870698 is an FDA 510(k) premarket notification submitted by Van-Tec, Inc. for the device "VAN-TEC PROSTATE BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on March 25, 1987. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Van-Tec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1987
Date Received
February 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Wheelchair
Device Class
Class I
Regulation Number
890.3920
Review Panel
PM
Submission Type

Other clearances by Van-Tec, Inc.

  • K880099 — VAN-TEC BLADDER EVACUATOR (March 2, 1988)
  • K880096 — VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP (March 2, 1988)
  • K880098 — VAN-TEC AUTO BIOPSY NEEDLE (March 2, 1988)
  • K880095 — BERGER PROSTATE CULTURE CYTOLOGY BRUSH (March 2, 1988)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K874112 — VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER (February 11, 1988)
  • K871777 — VAN-TEC REUSABLE HELICAL STONE BASKET (June 17, 1987)
  • K871779 — HELICAL STONE BASKET (DISPOSABLE) (June 17, 1987)
  • K870679 — VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE (March 30, 1987)
  • K870696 — VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH (March 30, 1987)

Other clearances for product code KNN

  • K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (March 4, 2022)
  • K942311 — DYNASTY U1-33 AGM (November 7, 1994)
  • K942309 — DYNASTY U1-31 (GELL/CELL) (November 7, 1994)
  • K942308 — DYNASTY GC 12400 (GELL/CELL) (November 7, 1994)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (November 7, 1994)
  • K942312 — ALDEN LINEAGE WHEELCHAIR CUSHION (May 26, 1994)
  • K942260 — ALDEN WHEELCHAIR CUSHION (May 26, 1994)
  • K933051 — ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION (October 12, 1993)
  • K925980 — PM (March 24, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)

FDA data resources