Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
FDA 510(k) K981458 · Karl Storz Endoscopy
510(k) numberK981458
Submission
- Device name
- Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
- Applicant
- Karl Storz Endoscopy
Culver City, CA, US - Received
- April 23, 1998
- Decision date
- May 20, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 cleared by the FDA?
Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 (K981458) received a 510(k) decision of Substantially Equivalent on May 20, 1998, 27 days after the submission was received.
What is the product code of K981458?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.