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510(k) K971941

AQUA SPRAY by Boyd Industries, Inc. — Product Code GEY

K971941 is an FDA 510(k) premarket notification submitted by Boyd Industries, Inc. for the device "AQUA SPRAY". The FDA issued a decision of Substantially Equivalent on August 14, 1997. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Boyd Industries, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1997
Date Received
May 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Boyd Industries, Inc.

  • K020833 — BOYD DELIVERY UNIT (August 8, 2002)

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)
  • K962789 — SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (August 14, 1996)

FDA data resources