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510(k) K863416

RAYLOR MINI-PROBE by Cedar Surgical, Inc. — Product Code HAO

K863416 is an FDA 510(k) premarket notification submitted by Cedar Surgical, Inc. for the device "RAYLOR MINI-PROBE". The FDA issued a decision of Substantially Equivalent on September 24, 1986. The device falls under product code HAO (Instrument, Surgical, Non-Powered), a Class I device regulated under 21 CFR 882.4535. Cedar Surgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1986
Date Received
September 3, 1986
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 by Cedar Surgical, Inc.

  • K873692 — RAYLOR(TM) DRILL STOP (December 17, 1987)
  • K872281 — RAYLOR FUSION FUNNEL (November 2, 1987)
  • K873690 — CEDAR(TM) PELVIC CUSHION (October 26, 1987)
  • K873691 — CEDAR(TM) RETRACTOR RING (September 28, 1987)
  • K864425 — RAYLOR(TM) DISSECTING HOOK (December 12, 1986)
  • K864426 — RAYLOR(TM) DEPTH GAUGE (November 26, 1986)
  • K864424 — RAYLOR(TM) PROTECTIVE RETRACTOR (November 26, 1986)
  • K864421 — RAYLOR(TM) PERIOSTEAL ELEVATORS (November 26, 1986)
  • K864422 — RAYLOR(TM) MALLET (November 24, 1986)
  • K864423 — RAYLOR(TM) OSTEOTOMES (November 24, 1986)

Other clearances for product code HAO

  • K220920 — Matreneu Percutaneous Balloon Compression Kit (September 7, 2022)
  • 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)
  • K942969 — AUTO SUTURE SPINAL NERVE HOOK (July 20, 1994)
  • K942968 — AUTO SUTURE SPINAL OSTEOTOME (July 20, 1994)
  • K942971 — AUTO SUTURE SPINAL DISSECTOR (July 20, 1994)
  • K942967 — AUTO SUTURE SPINAL CURETTE (July 20, 1994)
  • K923723 — SILICONE BRAIN SPATULA SET (August 12, 1992)

FDA data resources