Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel
FDA 510(k) K122563 · Hologic, Inc.
510(k) numberK122563
Submission
- Device name
- Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel
- Applicant
- Hologic, Inc.
Malborough, MA, US - Received
- August 22, 2012
- Decision date
- September 19, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIH – Hysteroscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
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| K243382 | RZ Resectoscope SystemHIH · Traditional | Rz Medizintechnik GmbH | 06/03/2025SE |
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| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)HIH · Special | Guangzhou Red Pine Medical Instrument Co., Ltd. | 08/02/2024SE |
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Questions and answers
When was Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel cleared by the FDA?
Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel (K122563) received a 510(k) decision of Substantially Equivalent on September 19, 2012, 28 days after the submission was received.
What is the product code of K122563?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.