Home / 510(k) Clearances / K901974

510(k) K901974

SELECTOR ULTRASONIC SURGICAL ASPIRATOR by Spembly Medical , Ltd. — Product Code LFL

K901974 is an FDA 510(k) premarket notification submitted by Spembly Medical , Ltd. for the device "SELECTOR ULTRASONIC SURGICAL ASPIRATOR". The FDA issued a decision of Substantially Equivalent on September 5, 1990. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Spembly Medical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1990
Date Received
May 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Spembly Medical , Ltd.

  • K925129 — SELECTOR (April 23, 1993)
  • K903303 — SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES (October 11, 1990)
  • K882568 — 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY (September 27, 1988)
  • K882963 — SPEMBLY MEDICAL 142 CRYO UNIT (August 8, 1988)
  • K882962 — SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) (August 8, 1988)
  • K874367 — VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (January 4, 1988)
  • K840497 — OBSTETRIC PULSAR TWO CHANNEL TENS (April 16, 1984)
  • K832385 — CRYOPROBES MC-1400-CRYOSURG-CONSOLE (September 12, 1983)
  • K832334 — CRYOMEDICS 5000 CRYOSURGICAL CONSOLE (August 12, 1983)
  • K832140 — CRYOMEDICS 5000 CRYOPROBES (August 12, 1983)

Other clearances for product code LFL

  • K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System (October 8, 2025)
  • K242894 — SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultr (June 18, 2025)
  • K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (March 24, 2025)
  • K241700 — Tenex 2nd Generation System (November 18, 2024)
  • K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System (July 11, 2024)
  • K233036 — Ultrasonic Surgical System (June 18, 2024)
  • K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System (July 11, 2023)
  • K231117 — neXus Ultrasonic Surgical Aspirator System (June 23, 2023)
  • K221790 — HARMONIC 700 Shears (February 28, 2023)
  • K223770 — Sonopet 1Q 3 7cm 1Q Large (February 16, 2023)

FDA data resources