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510(k) K840370

SURG-A-STAT VASECTOMY TIP by Suncoast Medical Manufacturers, Inc. — Product Code GET

K840370 is an FDA 510(k) premarket notification submitted by Suncoast Medical Manufacturers, Inc. for the device "SURG-A-STAT VASECTOMY TIP". The FDA issued a decision of Substantially Equivalent on July 23, 1984. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Suncoast Medical Manufacturers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1984
Date Received
January 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Suncoast Medical Manufacturers, Inc.

  • K841603 — ADJUST-A-TEMP MICRO (December 7, 1984)
  • K841509 — REPLACE-A-TIP ADJUSTABLE HIGH TEMP. (December 7, 1984)
  • K841604 — ADJUST-A-TEMP HIGH TEMPERATURE (December 7, 1984)
  • K841459 — REPLACE-A-TIP ADJUST. LOW TEMP.- (December 7, 1984)
  • K841591 — PYRO-TIP (October 31, 1984)
  • K840376 — SURG-A STAT LOOP TIP (October 26, 1984)
  • K840375 — SURG-A-STAT LOOP TIP 15 (July 23, 1984)
  • K840387 — SURG-A-STAT LOOP TIP 2 (July 23, 1984)
  • K840377 — SURG-A-STAT CARDIOVASCULAR TIP (July 23, 1984)
  • K841588 — SUN-LITE WHITE SPOT (May 22, 1984)

Other clearances for product code GET

  • K960473 — AESCULAP POWER SYSTEM HANDPIECE (March 7, 1996)
  • K955174 — SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY (January 22, 1996)
  • K942987 — NUCLEOTOME L KIT (October 30, 1995)
  • K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS (October 18, 1995)
  • K953433 — MIDAS REX TELESCOPING SYSTEM (September 15, 1995)
  • K953432 — ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS (September 14, 1995)
  • K952463 — GS & GS20 SURGICAL TOOL SYSTEM (July 17, 1995)
  • K952300 — MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) (May 26, 1995)
  • K914753 — AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP (June 11, 1992)
  • K910071 — PORTA GAS COMPRESSED GAS CYLINDER CART (March 22, 1991)

FDA data resources