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510(k) K870282

4 X 4 SPONGES, NON-STERILE by The Medical Group, Inc. — Product Code NAB

K870282 is an FDA 510(k) premarket notification submitted by The Medical Group, Inc. for the device "4 X 4 SPONGES, NON-STERILE". The FDA issued a decision of Substantially Equivalent on February 24, 1987. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. The Medical Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1987
Date Received
January 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze / Sponge,Nonresorbable For External Use
Device Class
Class I
Regulation Number
878.4014
Review Panel
SU
Submission Type

Other clearances by The Medical Group, Inc.

  • K911246 — THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 (June 6, 1991)
  • K901295 — PULMONAIR 40 PATIENT MANAGEMENT SYSTEM (March 30, 1990)
  • K881843 — PEDIATRIC HOSPITAL BED (October 26, 1988)
  • K881844 — MAGNUM 800(TM) MANAGEMENT SYSTEM (July 14, 1988)
  • K870284 — TRIANGULAR BANDAGE (February 24, 1987)
  • K870283 — 3 X 3 SPONGES, NON-STERILE (February 24, 1987)
  • K870285 — THERMOMETER SHEATHES, STERILE (GLASS) (February 12, 1987)
  • K863766 — DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY (October 30, 1986)
  • K863767 — GLASS MOUTH MIRRORS, REUSABLE (October 30, 1986)
  • K863769 — EVACUATOR TIPS (October 30, 1986)

Other clearances for product code NAB

  • K946015 — IVALON EXTERNAL SPONGE (February 27, 1995)
  • K940755 — ISOLYER (4X4, 8PLY) (May 2, 1994)
  • K931610 — OMNISORB II, NONWOVEN SPONGE, STERILE AND NON (June 24, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K926072 — K-BAND AND K-CREPE (March 19, 1993)
  • K915591 — STERILE GAUZE PADS (January 27, 1993)
  • K924650 — GAUZE SPONGES (January 11, 1993)
  • K923602 — ABSORBENT PAD -- MODIFICATION (December 7, 1992)
  • K923115 — CLINISORB (November 23, 1992)
  • K923378 — USP TYPE VII GAUZE SPONGES (October 6, 1992)

FDA data resources