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510(k) K923381

SOFT TISSUE EXPANDER by Acufex Microsurgical, Inc. — Product Code HWQ

K923381 is an FDA 510(k) premarket notification submitted by Acufex Microsurgical, Inc. for the device "SOFT TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on May 5, 1993. The device falls under product code HWQ (Passer), a Class I device regulated under 21 CFR 888.4540. Acufex Microsurgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1993
Date Received
July 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Passer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Acufex Microsurgical, Inc.

  • K961555 — ACUFEX TAG BIOABSORBABLE ANCHORS (July 10, 1996)
  • K961853 — PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER (June 21, 1996)
  • K954246 — ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW (February 15, 1996)
  • K952535 — ACUFEX ENDOBUTTON TAPE (February 8, 1996)
  • K953276 — ACUFEX TAG DELIVERY SYSTEM (October 5, 1995)
  • K953459 — ACUFEX TAG ANCHOR (August 23, 1995)
  • K941740 — ACUFEX ROTATOR CUFF FIXATION BUTTON (June 30, 1995)
  • K944500 — ACUFEX PATELLAR BONE BLOCK SIZER (June 12, 1995)
  • K951859 — ACUFEX ENDOBUTTON PACK (June 9, 1995)
  • K946346 — ACUFEX TAG(R) BIOABSORBABLE ANCHORS (April 26, 1995)

Other clearances for product code HWQ

  • K970360 — MITEK SUTURE RETROGRADER (March 10, 1997)
  • K920621 — ACUFEX PASSING PINS AND SURGICAL WIRE (May 5, 1993)
  • K885311 — MENISCUS MENDER II LOOP (February 9, 1989)
  • K843592 — VICO MICRO SURGICAL INSTRUMENTS (October 5, 1984)
  • K841623 — SLOTTED SOFT-TISSUE INSTRUMENT (July 11, 1984)
  • K841622 — SOFT-TISSUE INSTRUMENT (July 11, 1984)
  • K811679 — SILASTIC TENDON PASSER H.P. (July 10, 1981)
  • K791960 — ROTH-KENNEDY PASSER (October 4, 1979)

FDA data resources