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510(k) K953677

LIGHTED FLEXGUIDE (MODIFICATION) by Scientific Sales Intl., Inc. — Product Code BSR

K953677 is an FDA 510(k) premarket notification submitted by Scientific Sales Intl., Inc. for the device "LIGHTED FLEXGUIDE (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on August 25, 1995. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Scientific Sales Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1995
Date Received
August 7, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Tracheal Tube
Device Class
Class I
Regulation Number
868.5790
Review Panel
AN
Submission Type

Other clearances by Scientific Sales Intl., Inc.

  • K940799 — FLEXGUIDE (August 18, 1994)
  • K860996 — SANASSAY IC TEST (March 30, 1987)
  • K862087 — SANTEST 1AP (December 3, 1986)
  • K861336 — IAP PLATE TEST (April 25, 1986)
  • K853285 — MYWASHER 5 (October 4, 1985)
  • K853284 — MYREADER 7 (October 4, 1985)
  • K853380 — SPR 2 AUTODILUTER (September 12, 1985)
  • K853379 — PLATE INCUBATOR (September 3, 1985)
  • K833022 — AIR UTERINE DISPLACER-AUD 120 (October 14, 1983)
  • K802416 — SALEM/RESCE INTUBATION GUIDE (October 23, 1980)

Other clearances for product code BSR

  • K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exc (August 11, 2017)
  • K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (September 5, 1996)
  • K954771 — TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRA (May 9, 1996)
  • K943104 — MOLLOY INTUBATING STYLETTE (April 18, 1996)
  • K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE (February 6, 1996)
  • K952100 — RUSCH ENDOTRACHEAL TUBE STYLET (August 8, 1995)
  • K952266 — SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (June 12, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K950380 — FLEXTITIP STYLETTE (February 10, 1995)
  • K944729 — STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (December 21, 1994)

FDA data resources