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510(k) K942022

FACE-IT SHIELD by Onyx Medical Corp. — Product Code LYU

K942022 is an FDA 510(k) premarket notification submitted by Onyx Medical Corp. for the device "FACE-IT SHIELD". The FDA issued a decision of Substantially Equivalent on July 8, 1994. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Onyx Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1994
Date Received
April 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Surgical Apparel
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Onyx Medical Corp.

  • K041679 — COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT (December 16, 2004)
  • K931690 — SPOON PLATE (June 7, 1994)
  • K931680 — CANNULATED CANCELLOUS SCREW (May 4, 1994)
  • K934614 — MINI FRAGMENT PLATE (May 4, 1994)
  • K931684 — EPIPHYSIS PLATE (May 4, 1994)
  • K931692 — T-PLATE (May 4, 1994)
  • K931681 — CANNULATED NAVICULAR SCREW (April 25, 1994)
  • K931691 — STRAIGHT MINI-PLATE (April 25, 1994)
  • K934616 — CANCELLOUS BONE SCREW (April 25, 1994)
  • K931687 — MULTIPLE FRAGMENT PLATE (April 25, 1994)

Other clearances for product code LYU

  • K011755 — STRYKER T4 HYTREL (R) TOGAS (June 22, 2001)
  • K965237 — NURSES BOUFFANT CAP (August 27, 1997)
  • K970988 — FAR-EAST BOUFFANT CAPS (July 10, 1997)
  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K961791 — DEPUY DISPOSABLE FILTER/HOOD (August 9, 1996)
  • K961454 — AMMI MAGNI-GUARD (July 25, 1996)
  • K945302 — SLOAN STA-DRI PANT PROTECTOR (March 19, 1996)
  • K954314 — ULTRAFIT LINERS (December 28, 1995)
  • K953089 — I-SPOUSE (October 16, 1995)
  • K952303 — SPLASH ASSIST (August 24, 1995)

FDA data resources