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510(k) K902850

ZEPPELIN INSTRUMENTS by Ruggles Corp. — Product Code HAO

K902850 is an FDA 510(k) premarket notification submitted by Ruggles Corp. for the device "ZEPPELIN INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on July 18, 1990. The device falls under product code HAO (Instrument, Surgical, Non-Powered), a Class I device regulated under 21 CFR 882.4535. Ruggles Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1990
Date Received
June 29, 1990
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 Ruggles Corp.

  • K903485 — TITANIUM MESH (February 21, 1991)
  • K902818 — MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT (September 20, 1990)
  • K902819 — LAMINECTOMY ROGEUR (August 9, 1990)
  • K893415 — TRANS-ORAL DEPTH GAUGE (June 7, 1989)

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)
  • K942968 — AUTO SUTURE SPINAL OSTEOTOME (July 20, 1994)
  • K942971 — AUTO SUTURE SPINAL DISSECTOR (July 20, 1994)
  • K942969 — AUTO SUTURE SPINAL NERVE HOOK (July 20, 1994)
  • K942967 — AUTO SUTURE SPINAL CURETTE (July 20, 1994)
  • K923723 — SILICONE BRAIN SPATULA SET (August 12, 1992)

FDA data resources