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510(k) K220920

Matreneu Percutaneous Balloon Compression Kit by Shenzhen Shineyard Medical Device Co. , Ltd. — Product Code HAO

K220920 is an FDA 510(k) premarket notification submitted by Shenzhen Shineyard Medical Device Co. , Ltd. for the device "Matreneu Percutaneous Balloon Compression Kit". The FDA issued a decision of Substantially Equivalent on September 7, 2022. The device falls under product code HAO (Instrument, Surgical, Non-Powered), a Class I device regulated under 21 CFR 882.4535.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2022
Date Received
March 30, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Non-Powered
Device Class
Class I
Regulation Number
882.4535
Review Panel
NE
Submission Type

Other clearances for product code HAO

  • K940973 — MULLAN GANGLION MICROCOMPRESSION SET (September 29, 1995)
  • K951492 — RIB RESECTOR (May 18, 1995)
  • K943115 — AUTO SUTURE PITUITARY SPINAL RONGEUR (July 25, 1994)
  • K942970 — AUTO SUTURE SPINAL ELEVATOR (July 20, 1994)
  • K942967 — AUTO SUTURE SPINAL CURETTE (July 20, 1994)
  • K942969 — AUTO SUTURE SPINAL NERVE HOOK (July 20, 1994)
  • K942971 — AUTO SUTURE SPINAL DISSECTOR (July 20, 1994)
  • K942968 — AUTO SUTURE SPINAL OSTEOTOME (July 20, 1994)
  • K923723 — SILICONE BRAIN SPATULA SET (August 12, 1992)
  • K910226 — DURAL DISSECTORS (February 12, 1991)

FDA data resources