| Device |
seal, cervical, mechanical, unpowered |
| Regulation Description |
Hysteroscope and accessories. |
| Definition |
Reduce fluid leakage from the cervix during hysteroscopic procedures. |
| Physical State |
These devices attach to the hysteroscope or sheath and contacts the cervix and forms a seal. They may be passive or may have simple mechanical action (e.g., springs) that facilitate contact between the distal tip and cervix to promote the seal. |
| Technical Method |
These devices are simple mechanical devices that attach to a hysteroscope and form a physical seal between the hysteroscope and the cervix. The mechanical seal reduces leakage from the cervix during hysteroscopic procedures. |
| Target Area |
Vagina, cervix, uterus |
| Regulation Medical Specialty |
Obstetrics/Gynecology |
| Review Panel |
Obstetrics/Gynecology |
|---|
| Product Code | QHZ |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
884.1690
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
