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510(k) K974327

WINGED NEEDLE HOLDER by Phx Technologies Corp. — Product Code FHQ

K974327 is an FDA 510(k) premarket notification submitted by Phx Technologies Corp. for the device "WINGED NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on January 9, 1998. The device falls under product code FHQ (Holder, Needle, Gastroenterologic), a Class I device regulated under 21 CFR 876.4730. Phx Technologies Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1998
Date Received
November 18, 1997
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 Phx Technologies Corp.

  • K971123 — STONE EXTRACTOR (June 27, 1997)
  • K954508 — RETRACTOR (November 14, 1995)
  • K954510 — RRIANGLE KNIFE (November 14, 1995)
  • K954507 — RETROGRADE KNIFE (November 14, 1995)
  • K954509 — PROBE KNIFE (November 14, 1995)
  • K954463 — DISSECTING OBTURATOR (October 23, 1995)
  • K954459 — CONICAL OBTURATOR (October 23, 1995)
  • K954476 — PROBE (October 23, 1995)
  • K954458 — BOAT NOSE OBTURATOR (October 23, 1995)
  • K954464 — CARPAL TUNNEL SLOTTED CANNULA (October 23, 1995)

Other clearances for product code FHQ

  • K924196 — LAPAROSCOPIC NEEDLE HOLDER (June 25, 1993)
  • 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