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510(k) K924196

LAPAROSCOPIC NEEDLE HOLDER by Nusurg, Inc. — Product Code FHQ

K924196 is an FDA 510(k) premarket notification submitted by Nusurg, Inc. for the device "LAPAROSCOPIC NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on June 25, 1993. The device falls under product code FHQ (Holder, Needle, Gastroenterologic), a Class I device regulated under 21 CFR 876.4730. Nusurg, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1993
Date Received
August 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Needle, Gastroenterologic
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Nusurg, Inc.

  • K924792 — MULTIPLE PURPOSE FORCEPS (April 28, 1994)
  • K930610 — TALC DISPENSER SYRINGE (November 4, 1993)
  • K924517 — AVITENE DISPENSER SYRINGE (October 27, 1993)
  • K924372 — LAPAROSCOPIC NERVE HOOK (July 30, 1993)

Other clearances for product code FHQ

  • K974327 — WINGED NEEDLE HOLDER (January 9, 1998)
  • K930330 — ENDOSCOPIC NEEDLEHOLDER, MODIFICATION (June 8, 1993)
  • K920706 — MAGNETIC POINT GUARD FOR SURGICAL NEEDLES (May 26, 1993)
  • K851779 — 25-100,25-220 VARIOUS NEEDLE HOLDERS (June 20, 1985)
  • K851780 — 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS (June 20, 1985)
  • K771859 — NEEDLE HOLDER, MICROVASCULAR (October 4, 1977)

FDA data resources