Home / 510(k) Clearances / K960621

510(k) K960621

EXPANDACELL INSTRUMENT WIPE by Shippert Medical Technologies Corp. — Product Code GEC

K960621 is an FDA 510(k) premarket notification submitted by Shippert Medical Technologies Corp. for the device "EXPANDACELL INSTRUMENT WIPE". The FDA issued a decision of Substantially Equivalent on April 1, 1996. The device falls under product code GEC (Brush, Scrub, Operating-Room), a Class I device regulated under 21 CFR 878.4800. Shippert Medical Technologies Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1996
Date Received
February 13, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Scrub, Operating-Room
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Shippert Medical Technologies Corp.

  • K102117 — TISSU TRANS FILTRON SYRINGE FILL (August 6, 2010)
  • K092482 — TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 (December 4, 2009)
  • K092022 — TISSU TRANS HARVEST TUBING (August 17, 2009)
  • K050797 — TISSU-TRANS (July 13, 2005)
  • K964855 — EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD (March 4, 1997)
  • K964334 — EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) (December 9, 1996)
  • K963704 — MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE (November 26, 1996)
  • K962133 — EXPANDACELL INJECTO-PAK (August 1, 1996)
  • K960228 — EXPANDACELL INJECTO-PAK NASAL PACK (February 27, 1996)
  • K955593 — EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY (December 22, 1995)

Other clearances for product code GEC

  • K971473 — IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK (July 7, 1997)
  • K900691 — BIODYNE INSTRUMENT WIPES (March 8, 1990)
  • K896085 — SURGI-BRUSH (November 8, 1989)
  • K875033 — STERILE SCRUBBY SCRUB BRUSH (February 19, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K872823 — DELTA SCRUB (January 7, 1988)
  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • K870258 — BIOSCRUB SURGICAL SCRUB BRUSH (February 24, 1987)
  • K854232 — PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES (December 10, 1985)

FDA data resources