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510(k) K812569

SHERWOOD WATER TRAP by Sherwood Medical Co. — Product Code BYH

K812569 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "SHERWOOD WATER TRAP". The FDA issued a decision of Substantially Equivalent on September 25, 1981. The device falls under product code BYH (Drain, Tee (Water Trap)), a Class I device regulated under 21 CFR 868.5995. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1981
Date Received
September 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drain, Tee (Water Trap)
Device Class
Class I
Regulation Number
868.5995
Review Panel
AN
Submission Type

Other clearances by Sherwood Medical Co.

  • K981365 — MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS (November 25, 1998)
  • K960982 — MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. A (December 23, 1996)
  • K962880 — SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM (December 9, 1996)
  • K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC C (August 5, 1996)
  • K960677 — KANGAROO JEJUNAL FEEDING SYSTEM (May 13, 1996)
  • K960632 — KANGAROO FEEDING TUBE PLACMENT STYLET (May 9, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)
  • K954429 — KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT (March 8, 1996)
  • K954525 — SENSI-TOUCH EPIDURAL ANESTHESIA FILTER (January 19, 1996)
  • K950201 — ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (December 15, 1995)

Other clearances for product code BYH

  • K946057 — AQUALARM MOISTURE SENSOR MODEL P85000 (May 5, 1995)
  • K932722 — CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM (August 6, 1993)
  • K921624 — DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (June 30, 1992)
  • K900047 — THAYER SUCTION EVACUATION CONDENSATE COLLECTION (April 23, 1990)
  • K897057 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (March 16, 1990)
  • K895479 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (March 9, 1990)
  • K900591 — VENT-TRAP CAT# WR1000 (March 9, 1990)
  • K885088 — THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM (January 12, 1989)
  • K882739 — INTERTECH LARGE VOLUME WATER TRAP (LVW) (August 9, 1988)
  • K881790 — SAFETY DRAIN (June 21, 1988)

FDA data resources